Carnegie Pharmaceuticals
Pharmaceutical developer and contract manufacturer operating R&D laboratories and GMP manufacturing facilities in Delran, NJ. Provides formulation development and scale-up, analytical method development and testing, regulatory dossier support and labeling, GMP commercial manufacturing and packaging of solid oral dosage forms, oral suspensions/granules, topical and ophthalmic products, and end-to-end development-to-commercial supply services for third parties and internal brands. Publishes product safety data sheets and prescribing information and maintains occupational safety and hazardous-drug handling procedures.
Industries
Nr. of Employees
small (1-50)
Carnegie Pharmaceuticals
New Jersey, Saint Patrick, Trinidad and Tobago, North America
Products
Erythromycin ethylsuccinate granules for oral suspension (200 mg/5 mL and 400 mg/5 mL equivalents)
Reconstitutable granule formulations intended for pediatric and adult oral use; documentation includes reconstitution instructions, recommended storage conditions, hazard classification, SDS and prescribing information.
Erythromycin ethylsuccinate film-coated tablets (400 mg)
Oral film-coated tablet formulation intended for adults and older pediatric patients; prescribing information and stability/handling details are provided.
Balsalazide disodium capsules, 750 mg
Aminosalicylate capsule formulation indicated for treatment of mildly to moderately active ulcerative colitis; labeling includes adult and pediatric dosing, storage conditions, contraindications and monitoring recommendations.
Famotidine powder for oral suspension USP, 40 mg/5 mL (powder for reconstitution)
Powder formulation for oral suspension providing famotidine 40 mg/5 mL after reconstitution; documentation includes handling, storage and overdosage guidance.
Commercial generic tablets and capsules across multiple APIs
Marketed solid oral dosage products spanning several therapeutic areas (including oncology, neurology, endocrinology, antivirals and hemostasis), supported by SDS and prescribing materials.
Lomustine capsules USP (10 mg, 40 mg, 100 mg)
Finished drug product containing lomustine supplied in capsule form for oncology use; documentation includes hazard classification (carcinogenicity, mutagenicity, reproductive toxicity), handling and engineering control recommendations, PPE guidance, and medical surveillance considerations.
Erythromycin ethylsuccinate granules for oral suspension (200 mg/5 mL and 400 mg/5 mL equivalents)
Reconstitutable granule formulations intended for pediatric and adult oral use; documentation includes reconstitution instructions, recommended storage conditions, hazard classification, SDS and prescribing information.
Erythromycin ethylsuccinate film-coated tablets (400 mg)
Oral film-coated tablet formulation intended for adults and older pediatric patients; prescribing information and stability/handling details are provided.
Balsalazide disodium capsules, 750 mg
Aminosalicylate capsule formulation indicated for treatment of mildly to moderately active ulcerative colitis; labeling includes adult and pediatric dosing, storage conditions, contraindications and monitoring recommendations.
Famotidine powder for oral suspension USP, 40 mg/5 mL (powder for reconstitution)
Powder formulation for oral suspension providing famotidine 40 mg/5 mL after reconstitution; documentation includes handling, storage and overdosage guidance.
Commercial generic tablets and capsules across multiple APIs
Marketed solid oral dosage products spanning several therapeutic areas (including oncology, neurology, endocrinology, antivirals and hemostasis), supported by SDS and prescribing materials.
Lomustine capsules USP (10 mg, 40 mg, 100 mg)
Finished drug product containing lomustine supplied in capsule form for oncology use; documentation includes hazard classification (carcinogenicity, mutagenicity, reproductive toxicity), handling and engineering control recommendations, PPE guidance, and medical surveillance considerations.
Services
End-to-end development and GMP manufacturing services for third-party clients, including formulation, analytical development, stability/packaging and commercial supply.
End-to-end development and GMP manufacturing services for third-party clients, including formulation, analytical development, stability/packaging and commercial supply.
Expertise Areas
- Pharmaceutical formulation development
- Solid and liquid dosage manufacturing
- Regulatory submissions and FDA interactions (ANDA/NDA) preparation
- Analytical method development and quality control testing
Key Technologies
- Reconstitutable oral suspension formulation
- Film-coated tablet and capsule production
- GMP primary and secondary packaging
- Analytical chemistry assays and stability testing
News & Updates
Received DEA manufacturing license covering Schedule II–V controlled substances.
Series of FDA approvals and commercial launches including oral suspensions and solid dosage generics; continued ANDA/NDA submissions.
Safety data sheet and product leaflet for lomustine capsules (including hazard classification, medical surveillance recommendations and containment guidance) published.
Updated prescribing information, SDS and artwork/job specification documents for erythromycin ethylsuccinate granules and tablet products with reconstitution and storage instructions and NDC listings.
Revised prescribing information and patient counseling material for balsalazide disodium capsules reflecting dosing, renal monitoring and adverse reaction updates.
Product and safety information for famotidine powder for oral suspension including storage, handling and overdosage guidance.
Received DEA manufacturing license covering Schedule II–V controlled substances.
Series of FDA approvals and commercial launches including oral suspensions and solid dosage generics; continued ANDA/NDA submissions.
Safety data sheet and product leaflet for lomustine capsules (including hazard classification, medical surveillance recommendations and containment guidance) published.
Updated prescribing information, SDS and artwork/job specification documents for erythromycin ethylsuccinate granules and tablet products with reconstitution and storage instructions and NDC listings.
Revised prescribing information and patient counseling material for balsalazide disodium capsules reflecting dosing, renal monitoring and adverse reaction updates.
Product and safety information for famotidine powder for oral suspension including storage, handling and overdosage guidance.